BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Lenses, Soft Contact, Extended Wear

    PMA: P830037 · Supplement: S040 · Decision May 15, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    56
    Registration Numbers
    56

    Basic Information

    Device Name
    Lenses, Soft Contact, Extended Wear
    Trade Name
    DURASOFT 3 (PHEMFILCON A) UV OPTIFIT TORIC AND SPHERICAL CONTACT LENSES
    PMA Number
    P830037
    Supplement Number
    S040
    Device Class
    FDA Class 3
    Product Code
    LPM
    Generic Name
    Lenses, soft contact, extended wear
    Regulation Number
    886.5925
    Medical Specialty
    Ophthalmic
    Advisory Committee
    Ophthalmic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    May 15, 1997
    Date Received
    December 18, 1996
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL TO ADD AN ULTRA VIOLET ABSORBER TO THE CLEAR AND LITETINE LATHE CUT POLYMER RODS FOR THE SUBJECT DEVICES. THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES DURASOFT(R)3 AND DURASOFT(R)3 UV (PHEMFILCON A) SPHERICAL AND OPTIFIT(R) TORIC CLEAR, LITETINT, COLORS, AND COLOR COMPLEMENTS SOFT (HYDROPHILIC) CONTACT LENSES (LATHE CUT) FOR EXTENDED WEAR WITH NO CHANGE IN THE CURRENTLY APPROVED INDICATIONS FOR USE.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LPM Lenses, Soft Contact, Extended Wear